NSI Pulsed Electromagnetic Field (PEMF) Biomarker Study

NCT03654014 | Withdrawn DMC FDA Device

• 1 other identifier: 14-113
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Pulsed Electromagnetic Field (PEMF) Reduction of CSF and Serum Biomarkers After Traumatic Brain Injury (TBI). The primary objective of this pilot study is to determine whether PEMF treatment (PEMF+) reduces the magnitude and duration of the increase in CSF and blood biomarkers after traumatic brain injury (TBI) compared to a PEMF untreated (PEMF-) group. Values in both groups are compared to uninjured brain CSF and blood biomarker levels obtained from hydrocephalus patients undergoing ventriculo-peritoneal shunt placement. A secondary objective of this pilot study is to determine whether PEMF treatment improves the physiologic status of the brain as evaluated by brain tissue monitors of thermal dilution cerebral blood flow (CBF), intracranial pressure (ICP), and tissue PO2 (PbtO2). Improved physiologic status would be reflected by increased CBF, PbtO2, and reduced ICP. Improved physiologic status may also be inferred from derived variables reflecting improved cerebrovascular and intracranial pressure autoregulation. A tertiary objective of this pilot study is to obtain preliminary data on the relationship between the time course and magnitude of post-TBI CSF and blood biomarker levels as they relate to three month outcome by Glasgow outcome score extended (GOSE) and modified Rankin Score (mRS).

Conditions

Traumatic Brain Injury

Keywords

Pulsed Electromagnetic Field therapy; Traumatic Brain Injury; Neurologic outcome; Cerebrospinal fluid biomarkers; serum biomarkers

Outcome Measures

Primary Outcomes (1)

• CSF and serum biomarkers

  CSF and serum biomarkers: Magnitude of increase and rate of decrease in patients treated with SofPulse active and Sofpulse inactive and both compared to CSF and serum biomarkers in control normal pressure hydrocephalus.

  CSF and serum collection from Zero to 7 days after injury

Secondary Outcomes (3)

• Glasgow Coma Score

  Admission, daily for 7 days, discharge from hospital and one and three months

• Glasgow Outcome Score Extended

  Admission, daily for 7 days, discharge from hospital and one and three months

• Modified Rankin Scale

  Admission, daily for 7 days, discharge from hospital and one and three months

Study Arms (3)

SofPulse active

EXPERIMENTAL

SofPulse active group. Patients who will be treated with the SofPulse activated on their heads for up to seven days in intensive care or as long as they are in the unit The PEMF device is kept on throughout and provides a 15 min pulsed treatment every hour.

Device: SofPulse

SofPulse inactive

PLACEBO COMPARATOR

SofPulse inactive. The SofPulse will be placed on the patient's head but not activated for as long as they are in intensive care.

Device: SofPulse

Normal pressure hydrocephalus

SHAM COMPARATOR

CSF and serum samples from 15 normal pressure hydrocephalus patients will be used to compare CSF and serum biomarker levels in the 30 TBI patients.

Device: SofPulse

Interventions

SofPulse DEVICE

SofPulse PEMF device treatment of the brain after traumatic injury

Normal pressure hydrocephalus; SofPulse active; SofPulse inactive

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old GCS \<9 Male or Female Placement of multimodality monitoring Hummingbird device or an External Ventricular Drain as part of clinical treatment/care.
• Multimodality monitoring as part of clinical treatment/care

You may not qualify if:

• Pregnant Vulnerable population: Prisoners, No legally authorized representative (LAR). Patients with implanted metallic leads. Implants include cardiac pacemakers/defibrillators, cochlear implants, bone growth stimulators, deep brain stimulators, spinal cord stimulators and other nerve stimulators.
• Patients without multimodality monitoring or an EVD/Hummingbird Device

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Edwin M Nemoto, PhD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Honest broker will determine and record PEMF+ and PEMF- treated patients keeping investigator team blinded as to treatment until data analysis has been completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Model Details: Double blinded treatment with PEMF+ and PEMF- groups with CSF and serum biomarkers compared to values from patients with normal pressure hydrocephalus.

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: August 31, 2018
• Study Start: February 12, 2018
• Primary Completion: April 7, 2020
• Study Completion: April 7, 2020
• Last Updated: June 15, 2023

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)